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Alveolar Ridge Augmentation Using Porous Polyethylene Membrane and Composite Allograft for Staged Implant Placement: A Prospective Clinical, Radiologic, Histomorphometric and Volumetric Study

Alveolar Ridge Augmentation Using Porous Polyethylene Membrane and Composite Allograft for Staged Implant Placement: A Prospective Clinical, Radiologic, Histomorphometric and Volumetric Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171010005
Enrollment
Unknown
Registered
2017-10-10
Start date
2017-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertical single&#45

Interventions

The alveolar bone defects are surgically accessed to fully expose the bone augmentation site under oral local anesthesia. The surgical site is prepared for higher bone regeneration potential. A novel
the mucoperiosteal flaps are closured by horizontal mattress suturing and interrupted suturing.
Experimental Procedure/Surgery
surgical procedure of guided bone regeneration

Sponsors

Khon Kaen University, Faculty of Dentistry
Lead Sponsor
Khon Kaen University&#44
Collaborator
Graduate School,National Metal and Materials Technology Center (MTEC)&#44
Collaborator
Thailand,Khon Kaen University Neural Science Fund
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 67 Years

Inclusion criteria

Inclusion criteria: Generally healthy adult patients (ASA Ⅰ, Ⅱ) ranging 20-65 years old; Good oral hygiene and periodontal conditions (full-mouth plaque and bleeding score ≤ 25%); Single-tooth vertical or combined alveolar defect in posterior mandible; Alveolar bone defects ranging 2-6 mm below buccal cemento-enamel junction (CEJ) connection line of two adjacent teeth. Narrow flat edentulous ridge leads to larger crown-implant ratio, unsatisfactory esthetics, unpredictable implant integration and long-term prognosis than normal ridge; Available bone height smaller than implant length selected;

Exclusion criteria

Exclusion criteria: Severe systemic disorders that contraindicate oral surgeries; History of head and neck malignancy and related chemoradiotherapy; Long&#45;term use of steroid or immunological therapy (≥ 6 months); Severe osteoporosis (≥ 2 fragility fractures); Oral / intravenous bisphosphonate therapy ≥ 5 years; Pregnancy and lactation for female patients; Interocclusal restoration height available < 4.0 mm at edentulous area; Severe tempromandibular joint (TMJ) disorders and parafunctions; Bone augmentation procedure at the same site within the past one year; Additional soft tissue augmentation procedures at the same site within the past six months; Active&#44; acute mucosal&#44; periodontal and skeletal lesions; Heavy drinkers (≥ 1 drink / day for women or 2 drinks / day for men); Heavy smokers (≥ 10 cigarettes / day).

Design outcomes

Primary

MeasureTime frame
DMB (distance from matrix to bone) 1. During GBR procedure; 2. 6 months after GBR periodontall probe (0.1 mm),Attachd Gingival Width (AGW) 1. During GBR procedure; 2. 6 months after GBR periodontal probe (0.1 mm),Horizontal Alveolar Width (HAW) 1. During GBR procedure; 2. 6 months after GBR periodontal probe (0.1 mm),Available Bone Height (ABH) 1. During GBR procedure; 2. 6 months after GBR CBCT (0.1 mm)

Secondary

MeasureTime frame
Implant stability quotient (ISQ) 1.at implant placement; 2. 4 months after implant placement Resonance Frequency Analysis (Osstell ISQ),Mesial Implant Exposure (MIE): 1.at implant placement; 2. 4 months after implant placement periapical film,Distal Implant Exposure (DIE): 1.at implant placement; 2. 4 months after implant placement periapical film,Buccocclusal area (BOA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Buccoapical area (BAA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Lingocclusal area (LOA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Lingoapical area (LAA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),New bone percent (NB%) 6 months after GBR histomorphometry,Allograft particle percent (AP%) 6 months after GBR histomorphometry,Marrow space percent (MS%) 6 months after GBR histomorphometry,Connective tissue percent (CT%) 6 months after GBR histomorphometry

Countries

Thailand

Contacts

Public ContactJichuan Song

Faculty of Dentistry&#44; Khon Kaen Univesity

jchsong04270427@gmail.com0629499063

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026